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US8075535B2 - Pre-filled syringe with anti-tamper cap - Google Patents

Pre-filled syringe with anti-tamper cap Download PDF

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Publication number
US8075535B2
US8075535B2 US10/556,617 US55661704A US8075535B2 US 8075535 B2 US8075535 B2 US 8075535B2 US 55661704 A US55661704 A US 55661704A US 8075535 B2 US8075535 B2 US 8075535B2
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US
United States
Prior art keywords
tamper
tubular body
piston
flange
evident
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active, expires
Application number
US10/556,617
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English (en)
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US20070250017A1 (en
Inventor
Franck Carrel
Frederic Perot
Laurent Barrelle
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson France SA
Original Assignee
Becton Dickinson France SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson France SA filed Critical Becton Dickinson France SA
Assigned to BECTON DICKINSON FRANCE, S.A. reassignment BECTON DICKINSON FRANCE, S.A. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PEROT, FREDERIC, BARRELLE, LAURENT, CARREL, FRANCK
Publication of US20070250017A1 publication Critical patent/US20070250017A1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
    • A61M2005/3139—Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A61M5/31505—Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile

Definitions

  • the present invention relates to a device for medical use, of the prefilled syringe type comprising a piston, the said device comprising means for preventing access to the piston and its withdrawal once the said device has been filled with a medicinal liquid for example.
  • the syringes are filled in a sterile environment then packaged and possibly sterilized. It is between these two steps of filling and packaging that the internal chamber of these syringes must not be exposed or that the drug it contains must not be contaminated.
  • Document EP 0 738 517 describes an open clip that is slipped, while the piston actuating rod is already mounted, over the flange situated on the proximal part of the body of the syringe so as to prevent movement and/or withdrawal of the syringe piston.
  • this clip because it is open, can easily be removed and then reinstated on the flange of the syringe. It cannot therefore be used to deny access to the piston. Nor does it prevent withdrawal of the piston.
  • the present invention aims to remedy this problem by proposing a prefilled syringe equipped with a means making it possible both to prevent access to the piston and to prevent the piston from being withdrawn.
  • the present invention relates to a device for medical use, of the prefilled ready-to-use syringe type, comprising a tubular body comprising, at its distal end, a tip to take a needle and, at its proximal end, a flange, a piston able to slide inside the tubular body and arranged in an initial position defining, with the tubular body, an internal working volume at least partially filled with a medicinal liquid, a rod for actuating the piston extending beyond the proximal end of the tubular body, characterized in that a rigid cover is attached and fixed in a definitive way to the flange and has a central opening for the free translational passage of the actuating rod, and the said cover forms or comprises means of stopping the actuating rod in the proximal direction, and in that a plug is arranged to translate freely in the tubular body between the piston and the proximal end of the said body, said plug being made of a material resistant to puncturing with a needle.
  • the device according to the invention denies access to the piston and prevents the piston from being withdrawn. Indeed, in the device according to the invention, if any attempt is made at accessing the piston, an attempt is made to withdraw the actuating rod but, because of the shape of the central opening of the rigid cover which forms a means of stopping the actuating rod in the proximal direction, the actuating rod is halted by this rigid cover and the piston cannot be withdrawn. Furthermore, because of the presence of a stopper made of a material resistant to puncturing with a needle, access to the piston is impossible.
  • distal end of a component is to be understood as meaning the end furthest from the user of the device and the proximal end is to be understood as meaning the end closest to the user of the device.
  • the plug is arranged to translate freely in the tubular body between the piston and the proximal end of the said body.
  • the actuating rod is fixed at its distal end to the plug. In another embodiment of the invention, the actuating rod is not fixed to the plug.
  • a means of stopping in the proximal direction is fixed to the actuating rod between the cover and the plug.
  • the distal end of the actuating rod can be secured to the piston, for instance via the plug.
  • the plug and the piston are fixed in terms of translation, one on the other.
  • the cover is made of aluminium and is crimped to the flange of the device.
  • the cover is made of stainless steel and clipped in a definitive way to the flange.
  • the cover is made of plastic.
  • the cover is in the form of two halves of a ring, these being rigid and snap-fastened to one another, the two halves of the ring being able to be fixed to the flange, trapping it, each half if a ring comprising a lower platform comprising a semicircular opening corresponding to the external dimensions of the tubular body, and an upper platform comprising a semicircular opening designed for the passage of the actuating rod such that it is free in translational movement.
  • the two halves of the ring are symmetric.
  • the means of snap-fastening one half of the ring into the other are situated inside each ring half.
  • the ring that results from the snap-fastening one inside the other of the two ring halves has on its exterior surface no snap-fastening or disengagement means.
  • the plug is made of a material resistant to puncturing with a needle.
  • the thickness and the nature of the material of the plug are chosen so that the plug cannot be punctured with a needle.
  • the material of which the plug is made is chosen from plastics, polyolefin polymers, polycarbonates and blends thereof.
  • the plug is connected to the distal end of the actuating rod by screwing or snap-fastening of the said rod into the plug.
  • the plug is not secured to the piston.
  • the plug is connected to the piston by screwing of the said plug into the piston.
  • the actuating rod is equipped with at least one projection directed in a plane roughly radial with respect to the axis of the actuating rod, this projection being situated between the plug and the proximal end-of the tubular body.
  • FIG. 1 is a view in section of a device according to a first alternative form of the invention, once filled,
  • FIG. 2 is a view in section, once filled, according to a second alternative form
  • FIG. 3 is a part sectional view showing the connection between an actuating rod and a plug of a device according to the first alternative form depicted in FIG. 1 ,
  • FIG. 4 is a part sectional view showing the connection between an actuating rod, a plug and a piston according to the second alternative form depicted in FIG. 2 ,
  • FIG. 5 is an exploded perspective view of a cover belonging to a third alternative form of a device according to the invention.
  • FIG. 6 is a perspective view from above of a half ring of a cover according to FIG. 5 ,
  • FIG. 7 is a perspective view from beneath of a half ring of a cover according to FIG. 5 .
  • FIG. 8 is a perspective view of a cover according to FIG. 5 , once closed.
  • FIG. 1 depicts a device 1 comprising a tubular body 2 made of glass and a piston 3 able to slide inside the tubular body.
  • the tubular body 2 has, at its distal end 4 , a tip 5 to take a needle, for example a hollow hypodermic needle (not depicted), this tip being closed by a cap 6 , and, at its proximal end 12 , a flange 13 .
  • the lower end 7 of the piston defines inside the tubular body 2 an internal working volume 8 filled with a medicinal liquid 9 .
  • a plug 14 separate from the piston 3 , is fixed to the distal end 36 of an actuating rod 11 protruding from the proximal end 12 of the tubular body 2 .
  • the actuating rod 11 is not fixed to the plug 14 .
  • This plug 14 is arranged so that it is free to move in translation inside the body 2 , on the proximal side of the said piston 3 , bearing against the latter in the distal direction. There is therefore a bearing interface 10 between the plug 14 and the piston 3 .
  • a rigid aluminium cover 15 is crimped onto the flange 13 and has a central opening 23 for the passage of the actuating rod 11 such that it is free in translation in the proximal direction.
  • FIG. 2 depicts another alternative form of a device according to the invention.
  • the references that denote the same elements in FIGS. 1 and 2 are repeated.
  • the actuating rod 11 is equipped with radial projections 16 situated facing each other on that part of the actuating rod that lies inside the tubular body 2 .
  • These projections 16 forming stop means can collaborate with the cover 15 to prevent the piston 3 from being moved towards the proximal end 12 of the tubular body beyond a predetermined limit.
  • the cover 15 is made of stainless steel and is clipped in a definitive way onto the flange 13 using an annular collar 17 .
  • the cover 15 further comprises radial tabs 18 extending into the central opening 23 and capable of halting the translational movement, in the proximal direction, of the projections 16 .
  • FIG. 3 depicts an actuating rod 11 screwed using a screw or threaded part 19 into the plug 14 .
  • the piston 3 is not connected to the plug 14 .
  • it possible to access the piston 3 even if the actuating rod 11 is unscrewed, because of the presence of the plug 14 between the cover 15 and the piston 3 .
  • FIG. 4 depicts an actuating rod 11 fixed and clipped into the plug 14 .
  • the plug 14 is screwed onto the piston 3 using a screw or threaded part 20 .
  • the distal end of the actuating rod 11 is secured to the piston 3 via the plug 14 .
  • FIG. 5 depicts a cover 15 comprising a first half 211 of a ring 21 fixed to the flange 13 of the syringe and a second half 212 of a ring 21 ready to be clipped into the said first ring half 211 .
  • the half 211 of the ring 21 comprises a lower platform 22 comprising a semicircular opening 24 corresponding to the external dimensions of the tubular body 2 .
  • This half 211 of the ring 21 also comprises an upper platform 25 comprising a semicircular opening 26 the dimensions of which allow the actuating rod 11 to pass such that it is free in translational movement.
  • This upper platform 25 comprises a top face 27 and a bottom face 28 .
  • each half 211 or 212 of the ring 21 comprises, situated between its bottom platform 22 and its top platform 25 , two distinct recesses 29 and 30 and, on the other side, two distinct studs 31 and 32 .
  • the stud 31 of a first half 211 of a ring 21 has a cutout 33 able to clip into a cutout 34 of the recess 29 of the second half 212 of the ring 21 .
  • the stud 32 of a first half 211 of the ring 21 is able to clip into the recess 30 of the second half 212 of the ring 21 .
  • Each half 211 or 212 of the ring 21 also comprises two blocks 35 allowing the bottom platform 22 to be adjusted to suit the external dimensions of the tubular body 2 so as not to compromise the grip of the ring on the syringe.
  • FIG. 8 depicts the cover 15 of FIGS. 5 to 7 for which the two halves 211 and 212 of the ring 21 are clipped permanently together, around the tubular body 2 and on each side of the flange 13 . Once the cover 15 is fixed permanently on the tubular body 2 , it is impossible to access the interior of the said body without destroying this cover.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
US10/556,617 2003-05-26 2004-05-25 Pre-filled syringe with anti-tamper cap Active 2025-06-05 US8075535B2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
FR0306334 2003-05-26
FR03/06334 2003-05-26
FR0306334A FR2855413B1 (fr) 2003-05-26 2003-05-26 Seringue pre-remplie avec coiffe anti effraction
PCT/FR2004/001294 WO2004105840A1 (fr) 2003-05-26 2004-05-25 Seringue pre-remplie avec coiffe anti-effraction

Publications (2)

Publication Number Publication Date
US20070250017A1 US20070250017A1 (en) 2007-10-25
US8075535B2 true US8075535B2 (en) 2011-12-13

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
US10/556,617 Active 2025-06-05 US8075535B2 (en) 2003-05-26 2004-05-25 Pre-filled syringe with anti-tamper cap

Country Status (7)

Country Link
US (1) US8075535B2 (zh)
EP (1) EP1628695B1 (zh)
JP (1) JP2006528044A (zh)
CN (1) CN100548400C (zh)
ES (1) ES2727863T3 (zh)
FR (1) FR2855413B1 (zh)
WO (1) WO2004105840A1 (zh)

Cited By (19)

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WO2013178771A1 (en) 2012-06-01 2013-12-05 Novartis Ag Syringe
US20140194850A1 (en) * 2011-07-04 2014-07-10 Anteis Sa Accessory for a syringe
WO2014140095A1 (en) 2013-03-14 2014-09-18 Becton Dickinson France S.A.S. Injectable morphine formulations
WO2014140097A1 (en) 2013-03-14 2014-09-18 Becton Dickinson France S.A.S. Packaging system for oxygen-sensitive drugs
US9387292B2 (en) 2010-05-05 2016-07-12 Safety Syringes, Inc. Extended finger flange for syringe systems
US9511192B2 (en) 2012-12-28 2016-12-06 Daikyo Seiko, Ltd. Medical syringe
US9592346B2 (en) 2007-06-04 2017-03-14 Becton, Dickinson And Company Stoppers used in pre-filled syringes
US9649444B2 (en) 2007-06-04 2017-05-16 Becton, Dickinson And Company Positive displacement stopper for a pre-filled syringe
USD790691S1 (en) 2015-07-28 2017-06-27 West Pharmaceutical Services, Inc. Finger flange
USD812223S1 (en) 2015-05-18 2018-03-06 West Pharmaceutical Services, Inc. Finger flange
WO2019070218A1 (en) 2017-10-05 2019-04-11 Altera Tibbi Malzeme Sanayi ve Ticaret Anonim Sirketi INVIOLABLE INJECTOR LOCK AND RELATIVE LOCKING METHOD
US10537683B2 (en) 2016-11-03 2020-01-21 Johnson & Johnson Surgical Vision, Inc. Syringe finger grip
US10661030B1 (en) 2018-11-28 2020-05-26 Fresenius Kabi Usa, Llc Tamper evident cap for syringes
EP3381444B1 (en) 2012-07-03 2021-05-19 Novartis AG Syringe
US11298462B2 (en) 2019-03-15 2022-04-12 Eli Lilly And Company Automatic injection system
USD948714S1 (en) 2020-06-22 2022-04-12 KAISHA PACKAGING Private Ltd. Syringe plunger lock
WO2022086944A1 (en) * 2020-10-20 2022-04-28 Fresenius Kabi Usa, Llc Impact resistant and tamper evident system for prefilled syringe
US11452818B2 (en) * 2011-09-30 2022-09-27 Becton Dickinson France, S.A.S. Syringe assembly having a telescoping plunger rod
US11633543B2 (en) 2019-09-18 2023-04-25 Kaisha Packaging Private Limited Device for locking a plunger rod of a syringe after use and preventing re-use of the syringe, and syringe assembly

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JP2009240411A (ja) * 2008-03-28 2009-10-22 Terumo Corp 医薬品容器
GB0808389D0 (en) * 2008-05-09 2008-06-18 Owen Mumford Ltd Electrically actuated injector
DE102008028211A1 (de) * 2008-06-06 2009-12-10 Aesculap Ag Medizinische Spritze, gefüllt mit wässrigem Medium
DK2243505T3 (en) * 2009-04-23 2018-04-30 Bayer Healthcare Llc Spraying devices and methods of producing spraying devices
SG175102A1 (en) * 2009-04-30 2011-12-29 Sanofi Aventis Deutschland Axially adjustable connection of piston rod to piston for drive mechanism of a drug delivery device
WO2011022609A1 (en) * 2009-08-21 2011-02-24 Becton Dickinson France Sas Tamper evident tip cap and syringe
GB2475917B (en) * 2009-12-07 2015-12-16 Medical House Ltd Syringe flange protector
JP5897007B2 (ja) * 2010-08-06 2016-03-30 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング カートリッジホルダ及び薬物送達デバイス用のカートリッジユニットを組立てる方法
US20130018325A1 (en) * 2011-07-11 2013-01-17 Bristol-Myers Squibb Company Flange extender for use with an injection device and method of assembly
US8657793B2 (en) 2011-09-30 2014-02-25 Becton Dickinson France, S.A.S Space saving plunger cap and rod assembly
US9072560B2 (en) * 2011-10-12 2015-07-07 Warsaw Orthopedic, Inc. Implant removal aid for use with implants utilizing a data carrier
DK3003440T3 (da) * 2013-06-05 2021-04-06 Injecto Group As Stempel til anvendelse i en sprøjte med specifikt dimensionsforhold af en tætningsstruktur
US10850042B2 (en) * 2014-09-10 2020-12-01 Sio2 Medical Products, Inc. Three-position plungers, film coated plungers and related syringe assemblies
US11419985B2 (en) * 2016-09-12 2022-08-23 Min Wei Medication injection device
US20190290857A1 (en) * 2018-03-23 2019-09-26 Fresenius Kabi Usa, Llc Plunger rod for under-filled syringes
CA3189540A1 (en) 2020-07-16 2022-01-20 Invacare Corporation System and method for concentrating gas
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JP7414355B2 (ja) 2020-07-16 2024-01-16 ベンテック ライフ システムズ， インコーポレイテッド ガスを濃縮するためのシステムおよび方法

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US4592746A (en) * 1985-06-10 1986-06-03 Sherwood Medical Company Syringe and locking device and method of assembling same
US4711637A (en) * 1986-02-04 1987-12-08 Baxter Travenol Laboratories, Inc. Syringe lock
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Cited By (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9592346B2 (en) 2007-06-04 2017-03-14 Becton, Dickinson And Company Stoppers used in pre-filled syringes
US10183118B2 (en) 2007-06-04 2019-01-22 Becton, Dickinson And Company Stoppers used in pre-filled syringes
US9649444B2 (en) 2007-06-04 2017-05-16 Becton, Dickinson And Company Positive displacement stopper for a pre-filled syringe
US9802000B2 (en) 2010-05-05 2017-10-31 Safety Syringes, Inc. Extended finger flange for syringe systems
US10646657B2 (en) 2010-05-05 2020-05-12 Safety Syringes, Inc. Extended finger flange for syringe systems
US9387292B2 (en) 2010-05-05 2016-07-12 Safety Syringes, Inc. Extended finger flange for syringe systems
US20140194850A1 (en) * 2011-07-04 2014-07-10 Anteis Sa Accessory for a syringe
US11452818B2 (en) * 2011-09-30 2022-09-27 Becton Dickinson France, S.A.S. Syringe assembly having a telescoping plunger rod
US11179521B2 (en) 2012-06-01 2021-11-23 Novartis Ag Syringe
US11103644B2 (en) 2012-06-01 2021-08-31 Novartis Ag Syringe
EP3679922A1 (en) * 2012-06-01 2020-07-15 Novartis AG Syringe
WO2013178771A1 (en) 2012-06-01 2013-12-05 Novartis Ag Syringe
US11185635B2 (en) 2012-06-01 2021-11-30 Novartis Ag Syringe
US11110226B2 (en) 2012-06-01 2021-09-07 Novartis Ag Syringe
EP3777834B1 (en) 2012-06-01 2022-02-16 Novartis AG Syringe
US11147925B2 (en) 2012-06-01 2021-10-19 Novartis Ag Syringe
EP3858405A1 (en) * 2012-06-01 2021-08-04 Novartis AG Syringe
US12048837B2 (en) 2012-06-01 2024-07-30 Novartis Ag Syringe
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CN1795020A (zh) 2006-06-28
FR2855413A1 (fr) 2004-12-03
EP1628695A1 (fr) 2006-03-01
FR2855413B1 (fr) 2005-12-30
EP1628695B1 (fr) 2019-03-13
US20070250017A1 (en) 2007-10-25
WO2004105840A1 (fr) 2004-12-09
JP2006528044A (ja) 2006-12-14
ES2727863T3 (es) 2019-10-21
CN100548400C (zh) 2009-10-14

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